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A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Sponsor: Vericel Corporation
Summary
The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.
Official title: A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2018-10-24
Completion Date
2030-02
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
MACI
autologous cultured chondrocytes on porcine collagen membrane
microfracture
Arthroscopic microfracture treatment
Locations (15)
Stanford University School of Medicine
Palo Alto, California, United States
Shriners Hospital for Children Northern California
Sacramento, California, United States
University of California Davis Lawrence J. Ellison Ambulatory Care Center Orthopaedic Surgery
Sacramento, California, United States
Ochsner Health System-Elmwood
New Orleans, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Michigan Medsport Orthopaedic Surgery
Ann Arbor, Michigan, United States
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, United States
Akron Children's Hospital
Akron, Ohio, United States
The Ohio State University Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States
Penn Medicine University City
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia - The Hub for Clinical Collaboration
Philadelphia, Pennsylvania, United States
University Orthopedics, Inc.
East Providence, Rhode Island, United States
Texas' Children Hospital
Houston, Texas, United States
Children's Medical Center Plano
Plano, Texas, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States